Clinical trial · Observational
Genomic Grade Index (GGI): Feasibility in Routine Practice and Impact on Treatment Decisions in Early Breast Cancer
NCT01916837CI-TRIAL-00011602completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this prospective study the investigators sought to evaluate the feasibility of using the genomic signature - Genomic Grade Index (GGI) - in routine clinical practice and its impact on treatment recommendations.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sampling of tumor tissue | Other | — | UNRESOLVED |
| Sampling of tumor tissue after breast cancer surgery | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Single arm
- description
- Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery.
- interventionNames
- Other: Sampling of tumor tissue
- Other: Sampling of tumor tissue after breast cancer surgery
- Procedure: Sampling of tumor tissue after breast cancer surgery
Primary outcomes (1)
- measure
- The success rate in obtaining the Genomic Grade Index in clinical practice
- timeFrame
- 12 months
- description
- To evaluate the feasibility of implementing Genomic Grade Index in community hospitals in Belgium for breast cancer patients diagnosed with node negative and 1-3 node positive early-stage invasive breast cancer
Secondary outcomes (1)
- measure
- The impact of Genomic Grade Index results on adjuvant treatment decision
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Histologically confirmed invasive breast cancer meeting the following criteria: * T1, T2, or operable T3 disease * Zero to three positive lymph nodes and no distant metastases * Operable disease - Must have undergone breast-conserving surgery or mastectomy with either a sentinel node procedure or full axillary clearance Exclusion Criteria: * No other invasive cancer within the past 5 years except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer * No psychological, familial, sociological, or geographical condition that would preclude entering into a clinical study
References
Publications (1)
- DERIVEDMetzger-Filho O, Catteau A, Michiels S, Buyse M, Ignatiadis M, Saini KS, de Azambuja E, Fasolo V, Naji S, Canon JL, Delree P, Coibion M, Cusumano P, Jossa V, Kains JP, Larsimont D, Richard V, Faverly D, Cornez N, Vuylsteke P, Vanderschueren B, Peyro-Saint-Paul H, Piccart M, Sotiriou C. Genomic Grade Index (GGI): feasibility in routine practice and impact on treatment decisions in early breast cancer. PLoS One. 2013 Aug 19;8(8):e66848. doi: 10.1371/journal.pone.0066848. eCollection 2013. PMID 23990869